Zempilo, Amalungiselelo
"Octagam": imiyalelo ukusetyenziswa, izalathisi, imiphumela emibi
Libhekisela ichiza eza kuphucula amajoni omzimba, "Octagam". MiGaqo iya bakhumbula ukuba oku sisiyobisi kakhulu, yaye yaziswa kuphela esibhedlele, ngqongqo kagqirha. Zisetyenziswa replacement kunye nonyango immunomodulatory.
Ngohlobo ukukhulula ichiza nokubunjwa kwayo
It iveliswa kuphela ngokohlobo isisombululo ukumnika ukulungiselela "Octagam". Imiyalelo incamathele kuyo kwaye kuxhomekeke ukufunda inyanzelekile phambi kokuba isicelo. Isisombululo oluselubala, kunye unomona elityheli. Ichiza evela ezineengqayi zeglasi-20, 50, 100, 200 ml, avalwa ngesiciko irabha kunye burnishing aluminiyam zibekelelwe ibhokisi yekhadibhodi, apho ukongeza imiyalelo zokusetyenziswa yi ngumnini iplastiki-umnatha.
Le medicament iqulethe ngo-1 ml ubuncinane 95% immunoglobulin G. Isalathisi kulingana ngexabiso isixa protein equlethwe plasma igazi lomntu. izinto ezongezelelweyo kuhlanganiselo ichiza zezi:
- maltose;
- octoxynol;
- tributyl phosphate;
- amanzi inaliti.
Ichiza akufuneki ngumkhenkce okanye ukuveza ukuba kwelanga. Igcinwe kwiqondo lobushushu ka 2-8 ° C, kude ebantwaneni.
Pharmacology kunye pharmacokinetics
Drug "Octagam" (manual ulumkisa malunga Izimo kunye iziphumo zokusetyenziswa kweziyobisi kunokwenzeka) ichaphazela amajoni omzimba womntu yaye libhekisela immunoglobulins.
Amayeza yinxalenye yodidi immunoglobulin G, ekuthi kwezo nto kuphume antibodies iinkqubo ezahlukeneyo ezosulelayo emzimbeni. Ichiza iqulethe subclasses le immunoglobulin G, twatse plasma yabantu, phinda zonke iipropati kunye neempawu zayo. Ukuqaliswa ichiza kwi umzimba kubuyisela kwakhona amanqanaba nokuphungulwa ka IgG, kukhokelela ukuba kwimo yesiqhelo. IgG iimolekyuli ngenxa enzymatic nokuqhelana khemikhali zitshintshile. Umsebenzi omzimba unako ukusindisa ngokupheleleyo.
Xa Elungiselela "Octagam" ayikho ngaphezulu kwe-3% Polymer, intsalela libalwe kuba monomers kunye dimers imalunga 90%.
Xa uyila sisixhobo esisetyenziswayo igazi 3500 abanikele esempilweni ngokupheleleyo. Omzimba abafumanekayo kwi plasma aba bantu bahlala kulo ukulungiselela lingatshintshanga yaye busebenza ngokupheleleyo.
Emva ulawulo kweziyobisi ibe immunoglobulin umthambo nangoko G kuya kwegazi, nto leyo isasazwa va nemithambo kunye plasma. Ekusebenziseni i "Oktagama" imeko yomguli yokuphucula iintsuku 3-5. Lithathelwe amayeza ngomhla 24-36 ngosuku th. Kwisiqingatha ubomi yahlukile ukuba wonke kwaye kuxhomekeke kubudala yesigulane, sisidanga immunodeficiency. Immunoglobulin G okanye ezinye izakhiwo omzimba eziqulathe component esebenzayo, yatshatyalaliswa inkqubo reticuloendothelial.
Xa usebenzisa 'Octagam "?
Izicelo "Octagam" replacement unyango, xa kukho syndromes zamabanga immunodeficiency, kuqala kwiinto zonke, ukuba hypogammaglobulinemia enaso, agammaglobulinemia kunye Wiskott-Aldrich syndrome. Oku kuquka variable uhlobo immunodeficiency unclassifiable kunye immunodeficiencies ezidibeneyo.
Le inkomba ichiza kujongwe ezigula ezininzi, uhlobo lymphocytic ezondeleyo. amayeza eMiselwe izigulane izifo nezolo, kwaye une-HIV ebantwaneni.
Iyeza ifumene ukusetyenziswa kwayo amakhambi. Oko kukuthi, ukuba isetyenziswa purpura idiopathic thrombocytopenic (ITP), kunye nengozi eyonyukileyo ukopha. Kwakhona, ichiza lisetyenziswa phambi uqhaqho bunjani zegazi count. amayeza emiselweyo Guillain-Barré syndrome. Usebenzela inkomba isifo Kawasaki abantwana kunye nabantu abadala.
Sebenzisa 'Octagam "(application User ikuchaza ngokweenkcukacha indlela yolawulo umthamo ichiza) e allogeneic lomongo wethambo abohlukeneyo.
Izimo for infusions
Ilumkisa ukuba kuyimfuneko ukuze bayithathele Izimo ingqalelo phambi kokuba ukusetyenziswa "Octagam" imiyalelo ukulungiselela. Musa ukusebenzisa iyeza phambi hypersensitivity ukuba izinto enqila okanye immunoglobulins homologous.
Nangononophelo olukhulu amisele izigulane ichiza abatyebe kakhulu. Zinelungelo ukuthambekela ukuphuhlisa thrombosis. Uthetha into contraindicated xa kukho "une lwegazi, 'isifo seswekile, izifo nemithambo yegazi, nokuhlala eyandisiweyo ngaphandle izithuthi, nande kulo viscosity igazi.
Xa viscosity eliphezulu plasma immunoglobulin, faka egazini, ukumqumbisa umngcipheko iposi engabalulekanga, Embolism yemiphunga, stroke, thrombosis lwemithambo.
Amanyathelo kufuneka asebenzise eli chiza, izigulane ukusilela kwezintso kunye izigulane unyango hypovolemia nobunzi- arhente nephrotoxic. Ukuba kukho ulawulo nokoyika immunoglobulin-Inqanaba isifo sezintso, i "Oktagamom" uthomalaliso wayeka.
Izigulane ukusilela etsolo kwezintso kwimilo ngokunjalo abantu iingxaki thromboembolic of ngedriphu efakwa okanye inaliti, ichiza elo lilawulwa kancinci kwaye izixa ezincinci.
Impembelelo beziyobisi abasetyhini abakhulelweyo kunye phindeke ayikhange kufundwe, ngoko iiphiriyodi lubonise amayeza kufuneka isetyenziswe ngokuqaphela okukhulu. Ngaphandle koku, le nto ibonisa ukuba ukusetyenziswa immunoglobulins akuyonto naziphi iimpembelelo ezingalunganga ngexesha lokukhulelwa. Ichiza alunasiphumo kwi kwimveku kwaye aluchaphazeli usana kubisi lukamama. Immunoglobulins, ukuba ungene ubisi lwebele, musa esingenakubangela naliphi na umonakalo usana, kwaye ii-antibodies ekuwo, igalelo kuphela ukuyilwa sifo olomeleleyo.
Izikali
"Octagam" ichiza ilawulwa yegazi kuphela. Phambi kokuqala ukuba yothani ukuba lobushushu egumbini, inkqubo isisombululo. Ulwelo kufuneka ibe selubala ngokupheleleyo yaye akukho kwenze kunye turbidity.
ulawulo ichiza ngalinye irekhodwa kwimbali sifo. Kukho kwakhona kwenza inombolo inyanda iziyobisi kunye negama. Oku kwenziwa ukuphucula esweni imeko yesigulane. Ichiza eseleyo emva kokuba iimela, akanako zingagcinwa kwaye kufuneka kutshatyalaliswa.
Izinga yokuqala intshayelelo sostvlyaet ml 0,01 ukuya 0,02 / ubunzima bomzimba kg ngomzuzu omnye, njalo-njalo kangangesiqingatha seyure. Ezinereyithi medicament tolerability mhle angandiswa ku 0.12 ml / kg ubunzima bomzimba ngomzuzu.
Isixa kweziyobisi ixesha unyango azimisele ngayinye isigulane ngasinye. Yonke into ixhomekeke impendulo kwezonyango isigulana ethile, imeko yakhe isifo izifo.
Ukwenziwa kwezilungiso immunomodulating therapy kwi immunodeficiency zaseprayimari kubandakanya imilinganiselo immunoglobulin G ukuya 4.0-6.0 g / l, oko kulinganiswa phambi ukumnika nganye. Ukuze kufikelelwe umzobo uya kufuna iinyanga 3-6 zonyango. Ulawulo ithamo yokuqala 0.4-0.8 g / kg. Kamva ichiza yenziwa izigulane kwiiveki ezintathu 0.2 g / kg. Ukuze kufikelelwe koko bekujoliswe kuko immunoglobulin 6.0 g / L, isigulane kufuneka zibekwe kwi ngenyanga 0.2-0.8 g / kg of iziyobisi. Xa imbuyekezo umguli ukuba zikarhulumente eziqhelekileyo, ichiza uyaqhuba ukusetyenziswa kwiiveki 2-4, emva yokulinganisa uyondelelwano lwee- immunoglobulin G egazini. Oku kuya kukunceda ukuba ukhethe izinga eliphezulu.
Ukwenziwa kwezilungiso therapy iyeza kwenzelwa wegazi ezondeleyo lymphocytic, bekuza ukuya hypogammaglobulinemia zasesekondari ekwimo eziqatha, xa ezigula ezininzi, ngokunjalo kwi lokufunyaniswa "HIV positive" ebantwaneni kunye nezolo kunye neenkqubo esosulelayo. Ngaloo ndlela oyidlayo ngonyaka malunga 0.2-0.4 g / kg. Ubuninzi intshayelelo - kwiiveki 3-4.
Ngexesha unyango izigigaba nokoyika purpura idiopathic thrombocytopenic (ITP) lisetyenziswa umthamo 0.8-1.0 iziyobisi g / kg xa kuqhutywa ngosuku lokuqala. Ukuba kuyimfuneko, ukusetyenziswa kwakhona medicament eveliswa ngosuku 2-5 ngo-mali ka-0.4 g / kg. Ukuba amatyala exacerbation kwesi sifo zenzeke, ichiza ilawulwa kwakhona.
unyango syndrome Guillain-Barre ibandakanya kwi 0.4 g / kg beziyobisi ngosuku iintsuku 3-7. Kulo mzekelo, ukusetyenziswa kweziyobisi abantwana kulinganiselwe kakhulu.
isifo Kawasaki abantwana kunye nabantu abadala ziphathwe nge umthamo 1.6-2.0 g / kg. Ichiza ibhalwa idosi enye iintsuku 2-5. Avumelekile ekuqulunqeni iziyobisi eyodwa mali ka-2.0 g / kg. Ngexesha unyango oluqhubekayo yesigulana ngaxeshanye nokuqaliswa kwe "Oktagama" kuyimfuneko ukusebenzisa aspirin.
Immunoglobulin isetyenziswa emva ithambo allogeneic lomongo abohlukeneyo unyango wokulungiselela. Ulawulo isiyobisi ithintela kukuvela losulelo kunye nophuhliso onaso of "sihlume ithelekiswa host". Esithathwa isigulane ngasinye esikhethwe ngamnye. Kucetyiswa ukuba uqale ukusuka ne nedosi ye-0.5 g / kg nganye ngeveki. inkqubo Inaliti kufuneka aqale kwiveki phambi kokuba abohlukeneyo ezayo. Therapy waqhubeka iinyanga ezintathu emva kotyando. Ukuba kukho ukunqongophala rhoqo immunoglobulins, amayeza osetyenziswayo 0.5 g / kg ngenyanga nganye kangangoko kumxholo yabo ayiyi emva kuza kumanqanaba yesiqhelo.
imiphumela emibi
Ngokuxhomekeke ukufunda inyanzelekile phambi kokuba nokusebenzisa amayeza "Octagam" umyalelo manual. Uphuhliso iziphumo ebezingalindelekanga xa usebenzisa ichiza ixhomekeke ithamo kwaye izinga lolawulo.
Inaliti efakwa ne ichiza kungabangela leukopenia, hemolysis kunye anaemia ingathityazwa hemolytic. Xa unyango kunokwenzeka indlela ezimbi ngayo amajoni omzimba, leyo zibonakaliswa ngokubonakala hypersensitivity. Kwiimeko ezinqabe kuvela anaphylactoid kunye abasabela anaphylactic, sivakale sidumbile yobuso, angioedema.
Unyango HIV ebantwaneni kunye nonyango lwe nezinye izifo sisoloko sisenza yintloko. Kunqabile kwengqondo nokuhamba kwegazi, uchulumanco kakhulu, aseptic meningitis. Eli chiza ingenza intloko ebuhlungu, paresthesia kunye vertigo.
Ngexesha unyango, kukho amathuba apho livela khona iposi engabalulekanga. Kusenokubakho i ukubetha kwentliziyo ukwanda kunye tahikradiya. Maxa wambi unexhala cyanosis, hypotension kunye thrombosis. Kuyinto inqabile insufficiency yokujikeleza, deep vein thrombosis, lwegazi.
Ichiza kunokubangela ukusabela kwi inxalenye isixokelelwano sokuphefumla. Le ukusilela yokuphefumla, nokudumba yemiphunga, bamba umphefumlo. Imiphumo ezimbi zibonakaliswa ngendlela ukuthwala ekhohlela, bronchospasm, Embolism miphungeni.
Unyango kungabangela isicaphucaphu, reflex ukugabha, iintlungu esiswini, urhudo. Kwiimeko ezinqabe kakhulu, kukho nangokhwekhwe, urticaria kunye ukurhawuzelela. Kwezinye izigulane, emva ngokusebenzisa ichiza Wavuka dermatitis, alopecia, kunye pruritus.
Oku kunqabile bephawula ukusabela ezifana neentlungu kwindawo umva, myalgia kunye arthralgia. Abangakumbi unyango inokuphuhlisa insufficiency kwezintso, ukwanda serum creatinine, aphazamise ifiva, ukudinwa ngokugqithiseleyo, ubuhlungu asabela kwenzeka kuyo inaliti. Phakathi iziganeko yimiyalezo ezingalunganga waphawula Ukugodola, iintlungu esifubeni, ukuhlisa, umkhuhlane, irhashalala kunye eDayalayo. Kwiimeko ezinqabe kakhulu, izigulane kufuneka wegazi, ukothuka anaphylactic.
Imbonakalo iziphumo ebezingalindelekanga kunokwenzeka izigulane, ulawulo ichiza ukunyamezeleka ngaphambili kakuhle. "Octagam" ebangela ukwanda enzyme zesibindi kunye glucose lokuhlala kwizifundo igazi elebhu.
Xa ikhethiwe kakuhle ithamo zingenzeka overdosing iimpawu. Kudla ukugcinwa fluid emzimbeni, ukunyusa viscosity igazi, nto leyo uyaqapheleka abantu izifo zezintso, kwaye izigulane abadala.
Kuzo zonke iimeko ngasentla, unyango kwangumqondiso kucetyiswa.
oyi
Ichiza uyakwazi ukunciphisa iimpembelelo ephilileyo zokugonya intsholongwane okuncitshiswe isithuba seeveki ezintandathu ukuya kwiinyanga ezintathu. Ukuze uphephe oku, kufuneka ulinde emva kokuba isicelo of "Octagam" iinyanga ezintathu zamalungiselelo. Amayeza kunciphisa ukusebenza lwemasisi sokugonya ngomnyaka, ngoko ngaphambi kokuba nokusindlekwa le ugonyo kufuneka ijongwe izilwa titer yimasisi.
Unyango nalo eli chiza kungabangela eziliqela ziziphumo ebezingalindelekanga, ngoko kuyimfuneko ukuba zilandele ngqo imiyalelo idosi rate yolawulo. Ekuhambeni unyango kuyimfuneko ngawo onke amaxesha ukuba esweni impilo kwizigulane.
Izigulane Administrator immunoglobulin efakwa, kufuneka bafumane ngaphambi ukuxovwa eyaneleyo inkqubo, ukuqhuba nokubeka esweni output umchamo kunye creatinine negazi. Kuyimfuneko ukuba ukususa ngokupheleleyo ukusetyenziswa "yomtya" womchamo.
Ukuba kukho yokusabela kabi kuyimfuneko ukunciphisa izinga lolawulo iziyobisi okanye ngokupheleleyo uyeka ukuyisebenzisa. Uthomalaliso ixhomekeke ngokupheleleyo ebukhulwini kunye nohlobo iziganeko ezibi. Ukuba kukho njengomothuko, kuyimfuneko ukuba ukubhenela kuthomalaliso anti-njengomothuko, ekufuneka zidityaniswe kunye nonyango.
amaninzi kakhulu kubangela reactions ezibi santya yolawulo, ingakumbi esihanahanisa- kunye agammaglobulinemia nokusebenzisa immunoglobulin zaseprayimari. Iziphumo ezingalindelekanga kunokwenzeka xa odlulisela ngomonde immunoglobulin umenzi omnye komnye iziyobisi, yaye ukuba ixesha elininzi sele idlule ukususela nokuhlanganiswa yokugqibela.
Nokulawulwa kwezi zigulane (kwaye oku kuquka izigulane HIV-HIV) kufuneka kwenziwe rhoqo lonke ixesha nokuhlanganiswa lokuqala inyathelo, ingakumbi ngexesha leeyure yokuqala emva kokuba nkqubo. Izigulane kufuneka akukho ziziphumo ebezingalindelekanga, kufuneka ibe phantsi kweliso likagqirha emva ukumnika "Oktagamom" Imizuzu eli-20.
Ngexesha unyango kufuneka balumke standard ukuthintela usulelo ezinokwenzeka xa usebenzisa amayeza ezenziwe igazi lomntu okanye iplasma. Ezi zibandakanya ukukhethwa abaxhasi ezifanelekileyo, nokubeka servings ngamnye kunye namachibi plasma zabamakishi ezithile losulelo. Le nkqubo kufuneka ukuba ibandakanye amanyathelo ngenxa inactivation / kubulawe iintsholongwane.
Phezu kwayo yonke imigqalisela kwi unyango lwamachiza enjalo ke asikwazi, ukuvala amathuba udluliselo inani lee-arhente losulelo, iintsholongwane kunye namanye kwamagciwane. Zonke manyathelo angentla basebenza kukuzimisela iintsholongwane zigutyungelwe HIV, hepatitis B no C. I ubuncinane zinikeza abathwali parvovirus B19 kunye gipatita A. amava lwezonyango zee-arhente unyango equlethe immunoglobulin yabantu icebisa ukuba parvovirus B19 hepatitis A kwi unyango iziyobisi hayi data ethunyelwayo. Kubaluleke kakhulu kwi ukhuseleko antiviral kuba phambi kwimveliso amayeza engqinelanayo izilwa-buhlungu.
Ngexesha sicatshulwa kwekhosi zonyango antibodies nje yatshintshelwa egazini yomguli unakho ukunika iziphumo bobuxoki xa zokwenza uvavanyo serologic. Maltose equlethwe ekulungiseleleni unako bexoka bayasigqwetha kwinqanaba iswekile yegazi.
ukusebenza oluphuculweyo glucose igazi xi waphawula ngexesha ukususwa ichiza ukusuka eziphilayo okanye iiyure ezilishumi elinesihlanu emva kokuvalwa kwalo. Kulo mzekelo, kukho amathuba engeyizizo injongo insulin idosi ukuba kungabangela hypoglycemia. Ngoko ke, kuphela iindlela glyukozospetsificheskie yokuqingqa kwinqanaba glucose egazini ukuze isetyenziswe ukunyanga "0ktagamom". izixhobo Test for esweni eswekile yegazi kufuneka bakwazi ukumisela le parameter xa izigulane ezithatha amayeza kunye maltose.
Ukuba akunjalo lixesha, ngoko ivunyelwe ukugcina iziyobisi "Octagam" (ml-50 ne-100 ml) kwiqondo lobushushu ukuya + 25 ° C iinyanga ezintathu ngaphandle kokufaka zamabanga oko efrijini. Angasetyenziswayo kangangexesha elithile, ichiza kufuneka kutshatyalaliswa.
Amayeza alichaphazeli ukukwazi ukuqhuba kwaye ukwenza iintshukumo ezifuna kwiindibanisela ingqalelo ekhethekileyo ngayo lengqondo ngokukhawuleza.
Drug "Octagam": nabalingani
Eli yeza lineqela analogue ukuba buyisela kuye kwimeko abasweleyo, ngayo:
- "Biaven VI."
- "Veegum-yokuhlawula amatyala."
- "Venoglobulin".
- "Gabriglobin".
- "Gabriglobin-IgG».
- "Veegum-C."
- "Gamunex."
- "Gamma globulin Hooman".
- "I EVienna N.I.V. ".
- "Imbioglobulin".
- "Immunoglobulin".
- "Imbiogam".
- "Immunovenin".
- "Intratekt".
- "Sandoglobulin".
- "Endobulin".
- "Flebogamma 5%."
- "Humaglobin".
ababambeleyo Russian axabisa kakhulu kunoogxa babo amazwe. Xa kunjalo, zonke ezi machiza kakhulu ngokwaneleyo ukukhetha up kwaye kufuneka kufakwe kuphela ngugqirha, ngokusekelwe kwi imeko yesigulane.
"Octagam" Medicine: ixabiso
Iindleko ichiza kakhulu eliphezulu. Oko kuthengelwa 9,5-12 amawaka engange kunye ml 50 ichiza "Octagam". 100 Price ml malunga 20-24 amawaka engange.
Izimvo zezigulane amagqirha
Drug "Octagam" uye ncomo becala HIV. Ingakumbi ukwazisa abantu bayo umgangatho, lowo wayenceda kwakhona nge immunodeficiency kunye Guillain-Barré syndrome. Lidla ngokusetyenziswa kubantu abane-AIDS ukugcina impilo yabo. Waba ngempumelelo wegazi ezondeleyo lymphocytic, myasthenia gravis. Abasetyhini basebenzisa eli chiza ukuze kumitha izale umntwana.
Uninzi izigulane aneliseke yeendleko ichiza, bathi qaphela ukuba kunzima ukuthenga ezikhemisti. Abanye wayibiza ngokuba ubuthathaka, intloko ebuhlungu, kwaye umkhuhlane jikelele.
Oogqirha bathi ukuba ulungiselelo ecocekileyo, oko ako kakuhle umzimba, yaye ngokungafaniyo immunoglobulins zasekhaya okuba ukubangela komzimba.
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